Cleared Traditional

K772362 - AVF SET FOR SINGLE NEEDLE HEMODIALYSIS

K772362 is the FDA 510(k) clearance for AVF SET FOR SINGLE NEEDLE HEMODIALYSIS by Terumo America, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FIE) cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K772362 · Terumo America, Inc. · Gastroenterology & Urology device
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Mar 1978
Decision
80d
Days
Class 2
Risk

K772362 is an FDA 510(k) clearance for the AVF SET FOR SINGLE NEEDLE HEMODIALYSIS. Classified as Needle, Fistula (product code FIE), Class II - Special Controls.

Submitted by Terumo America, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 17, 1978 after a review of 80 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5540 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Terumo America, Inc. devices

Submission Details

510(k) Number K772362 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1977
Decision Date March 17, 1978
Days to Decision 80 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 130d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FIE Needle, Fistula
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5540
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FIE Needle, Fistula

All 23
Devices cleared under the same product code (FIE) and FDA review panel - the closest regulatory comparables to K772362.
VITAL CATHETER
K791489 · Hospal Medical Corp. · Oct 1979
UNIPUNCTURE CATHETER
K791490 · Hospal Medical Corp. · Oct 1979
A.V. FISTULA NEEDLE SET
K782021 · Cordis Corp. · Mar 1979
A.V. FISTULA NEEDLE SET (#344)
K771490 · Sorensen Research · Aug 1977
A.V. FISTULA NEEDLE SET (#364)
K771491 · Sorensen Research · Aug 1977
A.V. FISTULA NEEDLE SET (#351)
K771492 · Sorensen Research · Aug 1977